ECT’s expert team for services around biocidal products is experienced in preparing and reviewing dossier documents according to the Biocidal Product Regulation (BPR, Regulation EU 528/2012), and closely follows any updates of the relevant documents and guidance.
We have specialised in the areas of ecotoxicology and environmental fate. Our expertise includes exposure and risk assessments by using the current guidance documents, the Technical Agreements for Biocides (TAB), and the appropriate emission scenario documents (ESD) in combination with tools such as the European Union System for the Evaluation of Substances (EUSES).
In order to provide our customers with complete dossiers and registration services, ECT closely works together with experienced long-term partners to cover all information requirements.
ECT supports your company during the complete biocide registration process by providing the following services:
- Identification of the product type and specific information requirements
- Data mining, data gap analysis and literature search
- Dossier preparation, data management, evaluation and reporting with IUCLID 6
- Performing of the required ecotoxicological and environmental fate studies according to Good Laboratory Practice (GLP)
- Specifying exposure scenarios and conducting the environmental risk assessment
- Assessment of substances of very high concern (SVHC): PBT, vPvB, endocrine disruptors, and equivalent level of concern
- Classification, Packaging & Labelling (CLP) according to the Globally Harmonised System (GHS) and EU requirements
- Communication with the competent authority (pre- and post submission)
- Project coordination and communication with all participants
- Submission of the dossier documents to the competent authorities